Eight years after the hip implants were globally recalled, the Maharashtra Food and Drug Administration (FDA) has set up a five-member committee to fix compensation for patients who suffered adverse reactions after undergoing faulty articular surface replacement (ASR) implants by pharmaceutical giant Johnson & Johnson (J&J).
The committee is advertising and inviting applications and medical records from patients in Maharashtra who underwent the ASR implant to fix compensation amount for each. Till now, records with the FDA show 11 patients have submitted their medical documents.
In 2013, Johnson & Johnson had agreed to pay compensation of $2.5 billion to around 8,000 US citizens who sued the company after being fitted with faulty hip implants.
Dr Shivraj Ingole, radiologist with JJ Hospital and member of the committee, said a standardised formula has been decided based on guidelines by the central government. “We are ensuring that we give maximum benefit to patients who suffered adverse effects. The difficulty lies in not just how to measure anatomical deformity a decade after the surgeries were done, but also factoring the emotional stress caused by faulty implants. It is necessary to objectify that into a compensation component,” said Ingole.
A report by the Maharashtra FDA, which registered a first information report against the company in March 2013, shows J&J called for a recall in India in late 2010. Till then, DePuy Medical Private Limited, its subsidiary, had imported 15,829 implants in the country out of which only 1,295 medical devices were sent back. In Maharashtra, 4,700 patients underwent the hip implant between 2006 and 2010.
FDA official Madhuri Pawar, who investigated the case, said in her report submitted in 2013 that 68 patients had high ESR (erythrocyte sedimentation rate) value which indicated poisoning. In its report, the FDA found that the ASR implants led to cobalt and chromium ions leaching in body leading to muscular toxicity, pain and affecting mobility. “The compensation will be based on level of deformity caused by the implant. It may range between Rs 30 lakh and Rs 1.22 crore,” said Amrut Nikhade, joint commissioner, FDA, adding that so far four hearings have taken place.
Following the red flags raised by the Maharashtra FDA, the central government report found that J&J had suppressed key facts of the ASR implant surgery effects. Nikhade added that the Mahim police were yet to file a chargesheet in the case. The next hearing in the case is on December 11.